BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 8258153 · Received January 17, 2019

    Report

    Report Number
    2182208-2019-00124
    Event Type
    Injury
    Date Received
    January 17, 2019
    Date of Event
    December 24, 2018
    Report Date
    January 17, 2019
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR HIGH IMPEDANCE AND IT WAS FURTHER REPORTED THAT THE THRESHOLD INCREASED. THE PATIENT EXPERIENCED CHEST PAIN. THE RV LEAD WAS PROGRAMMED OFF. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48597 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R 407652 LEAD, DDBB1D1 ICD